Health & FDA Business

Health care is not only one of the world’s largest and fastest growing industries, but also one of the most highly regulated. By 2021, health care is expected to comprise 19.6 percent of U.S. GDP. This increased spending will open up greater possibilities for industry participants. Advances in technology and the increased use of integrated delivery systems are also creating new opportunities. All of these developments are leading to significant changes in the structure and organization of health care services for many providers and related businesses.

Greenberg Traurig’s Health & FDA Practice provides strategic legal counsel to many organizations along the health care supply chain, helping them respond proactively to the rapidly changing marketplace. Our interdisciplinary team brings together experienced attorneys from across the firm, including several who have served as in-house counsel for health care companies. Our experience as members of organizations firmly planted within the health care network, coupled with the firm’s broad capabilities in related disciplines – including corporate, finance, tax, antitrust, ERISA, litigation, restructuring, intellectual property and biotechnology – make Greenberg Traurig well positioned to advise our clients on virtually all facets of the industry.

We offer our clients the practical know-how that comes from firsthand experience working in their industries and in regulatory circles. Many of our team members previously served in government positions. Our Health & FDA Business Group co-chair served for 10 years as health policy director for the U.S. Senate Committee on Labor and Human Resources, drafting and interpreting many of the major health care laws enacted during the past 20 years, including the Patient Protection and Affordable Care Act (PPACA). Other members of our team have worked for the Department of Health and Human Services, Department of Justice, New York State Public Health Council, the District of Columbia Council’s Health Committee, New York State Department of Financial Services (DFS) Health Bureau as well as a variety of health care companies.

Recognitions and Awards

  • Modern Healthcare's Largest Law Firms - Greenberg Traurig is ranked on Modern Healthcare’s list of largest healthcare law firms, 2013-2016, and is currently ranked in the top 20
  • ABA Health Law Section's Top 10 Recognition List - The Membership Committee of the Health Law Section of the ABA ranked Greenberg Traurig in their list of top 10 firms for the Southeast & D.C. Regions, 2014-2016
  • The Legal 500 U.S. - Greenberg Traurig is ranked for Industry Focus - Health Care: Health Insurers, 2013-2016, and Industry Focus - Health Care: Service Providers, 2015-2016
  • U.S. News-Best Lawyers - Greenberg Traurig is ranked in National - Tier 1 U.S. News-Best Lawyers® "Best Law Firms" in Health Care Law, 2015-2017
  • Chambers and Partners USA - Greenberg Traurig is ranked in New York and Texas for Health Care.
  • LMG Life Sciences - Members of the group selected as "Life Science Stars," 2016
  • Dade County Bar Association - Member of the group was designated as a "Legal Luminary - Health Care." 2016
  • M&A Advisor Awards - Members of the group were selected as "Healthcare and Life Sciences Deal of the Year (from $10mm to $500mm)" for the Chapter 11 sale of ATLS Acquisition, LLC, dba Liberty Medical Supply, Inc., 2015
  • Global M&A Network’s Turnaround Atlas Awards - Members of the group were selected as "Turnaround of the Year - Small Markets" for the restructuring and sale of ATLS Acquisition, LLC (dba Liberty Medical), 2015
  • Team members are consistently ranked and recognized in Chambers & Partners USA, Super Lawyers, The Legal 500 U.S. and U.S. News-Best Lawyers

Our Clients

  • Assisted living companies
  • Clinical laboratories and biotech companies
  • Dietary supplement, food and cosmetic companies
  • Employer and provider trade organizations
  • Financial institutions
  • Health maintenance organizations
  • Hospitals and nursing homes
  • Long-term and sub-acute care providers
  • Managed care and insurance companies
  • Medical device manufacturers
  • Pharmaceutical companies
  • Physicians and physician groups
  • Provider networks
  • Tax-exempt institutions
  • Dentist and dentist groups
  • Sleep labs
  • Home health care
  • Home medical equipment

Legislation and Policy

  • Assist with the development of viable policy and legislative approaches
  • Evaluate and report on the political and policy environment and help formulate the most successful approaches possible for complex issues
  • Provide advice on the positioning and strategies through the legislative and administrative process to ensure that objectives are carried out consistent with policy objectives
  • Work at the federal and state levels to carry out policy and legislative strategies and respond to pending issues
  • Draft legislation and regulations concerning issues affecting our clients
  • Interact with important congressional leaders, stakeholders, policymakers and key opinion leaders
  • Provide comments to governmental agencies concerning proposed regulations
  • Regularly meet with representatives of various governmental agencies and legislative bodies to obtain early insight into the rapidly changing health care regulatory and reimbursement climate
  • Advise clients on impact of legislation and regulation, including fraud and abuse, reimbursement and coverage requirements
  • Maintain a focus on the FDA, the Medicare Advantage program and the Part D prescription drug benefit and assist the entities and providers involved

Fraud and Abuse, Self-Referral, HIPAA Compliance and Regulatory Compliance

  • Counsel clients concerning operational aspects of their business in light of pertinent federal and state fraud and abuse and self-referral prohibitions and restrictions
  • Advise on development, implementation and maintenance of corporate compliance plans and corporate integrity agreements
  • Assist providers, suppliers and practitioners in modifying operations and systems to comply with the Health Insurance Portability and Accountability Act (HIPAA) rules and regulations concerning health information privacy protections, standard electronic data requirements and electronic security standards

Joint Ventures

  • Counsel clients on the planning, development, implementation and operation of joint ventures designed to accomplish market definition, product focus and operational and financial efficiency
  • Structure both taxable and non-taxable entities, ranging from whole hospital ventures and diagnostic and sub-acute services to clinical laboratories and back-office support services
  • Draw on our team's wide-ranging experience handling tax, corporate, antitrust, fraud and abuse and self-referral, and reimbursement issues

Mergers, Acquisitions, Sales and Reorganizations

  • Represent clients in mergers and acquisitions
  • Advise clients engaged in the process of right sizing their organizations through targeted acquisitions and spin-offs
  • Counsel clients on restructuring their relationships with physician organizations
  • Represent long-term care and other sub-acute organizations on various aspects of their business relationships
  • Advise newly formed provider organizations on acquiring distressed hospitals, long-term care facilities and sub-acute providers

Licensing, Certificate of Need, Survey and Disciplinary Matters

  • Guide clients through the maze of applicable regulatory, licensure, certificate of need, certification and accreditation processes and requirements, at both the federal and state levels
  • Assist at the many stages of the process, from the preparation of applications and filings, to survey and disciplinary matters, to the analysis and response to enforcement actions, to representation of clients before the relevant agencies
  • Draw on our team's knowledge of the federal agencies, including the Centers for Medicare & Medicaid Services (CMS) and several state agencies, to help clients attain their objectives while avoiding the litigation or appeal process
  • Represent clients in the litigation and appeal process, as appropriate
  • Advise clients throughout the licensure and disciplinary process for individual health care providers
  • Represent clients in investigations and potential actions against providers' professional licenses


  • Provide a wide range of legal services to hospitals including, without limitation, medical staff issues, governance, contracting, regulatory compliance, employment, reimbursement issues and tax
  • Work closely with hospitals' in-house counsels

Long-Term and Sub-Acute Care

  • Represent a broad range of clients in the long-term care industry and sub-acute provider industry, including skilled nursing; home health; hospices; physical, occupational and speech-language therapy; and assisted living
  • Advise clients on transactional matters, licensing and certification, regulatory compliance, survey issues, disciplinary matters, reimbursement matters, administrative hearings and appeals, and legislative matters
  • Counsel clients on regulatory matters such as medical records, end-of-life issues, and patient discharge matters and hearings
  • Assist in implementing regulatory issues and practices related to prospective payment systems, consolidated billing arrangements, service caps and network participation and payor arrangements

Reimbursement and Program Compliance

  • Provide a wide range of services in connection with reimbursement from private payors, as well as from governmental payors, their related carriers and fiscal intermediaries
  • Assist with Medicare, Medicaid, CHAMPUS and private payor reimbursement issues and qualification at both the state and federal level

Managed Care and Insurance

  • Represent health maintenance organizations and health care insurers in merger and acquisition transactions, provider contracting matters, regulatory and legislative issues
  • Advise integrated delivery systems, multi-specialty and single-specialty carve-out networks on managed care contracting issues
  • Assist in the formation and operation of utilization management and third-party administrator companies

White Collar Criminal Defense

  • Advise clients in light of the increased federal and state focus on health care fraud and abuse
  • Work closely with the firm's litigation department in providing our clients, their officers, directors and key employees with representation in connection with investigations and trials involving fraud and abuse, false claims, program exclusion, money laundering, asset forfeiture, securities, environmental, antitrust, employee discrimination, obstruction of justice and RICO claims

Tax-Exempt Institutions

  • Work closely with Greenberg Traurig's tax, trusts and estates department to provide tax advice to tax-exempt hospitals, tax-exempt clinics, homes for the aged and medical education institutions
  • Counsel clients on the tax issues affecting tax-exempt health care organizations, including unrelated trade or business income, private inurement, intermediate sanctions, joint ventures with for-profit entities, obtaining of exempt status, physician practice acquisitions and physician compensation
  • Assist clients in structuring ambulatory surgical center joint ventures, joint operating agreements between tax-exempt hospitals and whole hospital joint ventures
  • Represent exempt organizations in connection with tax-exempt financing transactions
  • Advise on the organization and governance of not-for-profit corporations and compliance with state charitable solicitation laws

Antitrust and Trade Regulation

  • Work closely with Greenberg Traurig's antitrust and trade regulation practice on matters affecting the firm's health care clients
  • Provide antitrust advise and counseling to clients in such areas as mergers and acquisitions, pricing, exclusive and requirements contracts, exclusionary practices, networking and customer and territory limitations
  • Advise and defend companies regarding health care product or service promotional claims
  • Process Hart-Scott-Rodino analyses and filings
  • Defend potential mergers or acquisitions that are subject to federal or state governmental investigation

Restructuring & Bankruptcy

  • Work closely with GT's Restructuring & Bankruptcy practice to handle aspects of health care-related insolvencies and restructurings
  • Represent for-profit and non-profit hospitals, nursing home facilities, home health agencies, physician groups and other health care-related businesses in both Chapter 11 and out-of-court reorganizations
  • Represent creditors' committees, equity holders, landlords (including health care facility REITs) and other stakeholders in financially distressed health care businesses
  • Represent financing sources providing liquidity to health care providers
  • Assist clients in acquisitions and dispositions of financially troubled health care facilities and related assets
  • Draw on the experience of members of our restructuring & bankruptcy practice who have been instrumental in enacting the healthcare insolvency portions of the U.S. Bankruptcy Code, assisting in the drafting of the original bill and testifying before Congress in support of its adoption

FDA-Regulated Products

  • Represent companies that manufacture and market products regulated by the FDA that include drug prescription companies, biotechnology, medical device and food companies as well as pharmacies
  • Shepherd clients' product registrations, approvals and clearances through the appropriate regulatory process
  • Provide advice on critical issues such as product label and labeling requirements
  • Help clients through the government approval processes and policies that impact their products, such as procurement requirements and trade agreements
  • Connect clients with potential partners to advance their common interests
  • Represent both public and private entities before administrative and regulatory agencies
  • Counsel clients on IP matters that affect their businesses

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At Greenberg Traurig, we are committed to diversity and inclusion in the workplace. The individual attorneys at Greenberg Traurig are committed to nurturing diversity throughout the firm and creating an environment where differences are embraced and utilized creatively.

For us, diversity is about taking action - opening doors for lawyers.

That commitment is reflected by the fact that overall, 40 percent of Greenberg Traurig's attorneys worldwide are women or minorities as defined by the American Bar Association. As of Dec. 31, 2014, our U.S. employees, including attorneys and staff, who met the definition of minority persons reflected a total of 29 percent of our employment base. Approximately 32 percent of our U.S. attorneys and 52 percent of our U.S. employees are women.

Greenberg Traurig's commitment to diversity and inclusion goes beyond any single committee. Committees cannot nurture; they cannot mentor; they cannot create an environment where differences are embraced and utilized creatively. Committees do not lead. Our diverse attorneys however, can and do.

* We welcome and reflect the communities we represent better than any other major law firm in our markets.

* We do not simply rely on a "committee" to achieve this.

* We do so through a commitment to providing a fair opportunity for each of us to reach our full potential.

* We have the personal dedication of many at Greenberg Traurig who identify and bring into our firm this very special diversity.

* The Minority Law Journal 2014 Diversity Scorecard has recognized us as follows:
o No. 1 Ranking, African American Partners
o No. 1 Ranking, Hispanic American Non-Partners
o No. 2 Ranking, Hispanic American Partners

* The National Law Journal has previously recognized our attorneys as among:
o No. 2 Ranking, Female Partner Numbers, Female Scorecard (2013)
o "The 50 Most Influential Minority Lawyers in America" (Three) (2008)
o "The 50 Most Influential Women Attorneys" (Two) (2007)
o "The 100 Most Influential Attorneys in America"
(Two diverse attorneys; three total) (2006)

Diversity in Action: Fostering Diversity in the Profession and Preserving the Pipeline

Greenberg Traurig's Diversity Leadership Community has initiatives that focus on fostering an environment within the firm that supports and encourages diversity and inclusion, and increasing diversity in the profession by increasing access to a legal education for minority students. Helping today's law students and lawyers become tomorrow's business and legal leaders means a larger, more diverse marketplace and a greater pool of talented professionals. And that means more business opportunities for everyone - our firm, our colleagues and, most importantly, our clients.
In this way, our approach to diversity and inclusion mandates a high-level of personal responsibility with regard to the recruitment and retention of diverse attorneys. Attorneys in recruiting, hiring and supervisory roles are continuously made aware of the progress of our efforts. Our personal approach to diversity and inclusion means that Greenberg Traurig lawyers are active at their alma maters and at law schools local to their offices, participating in such programs as career panels; "Meet the Employer" days; and mock interviews, among others.

It has been, and continues to be, our goal to create a well-balanced workforce that contains a significant presence of minorities and women.

Greenberg Traurig creates and supports partner programs with women, minority, gay/lesbian or disability-focused bar associations. We attend and sponsor events at these organizations regularly throughout the United States. The firm works closely with national and local minority bars to address the fostering of diversity and inclusion in the profession on many levels. We support the work of several organizations, including MCCA, NAPABA, NASABA, NBA, NLGBTBA, HRC, HNBA and others.

Additionally, we provide funding through the Holly Skolnick Greenberg Traurig Fellowship Foundation for lawyers and law students to work with public interest groups. Through the Foundation, Greenberg Traurig serves as the largest sponsor of Equal Justice Works Fellowships in the United States and has invested approximately $8 million to support, in whole or in part, almost 127 Equal Justice Works Fellows since 1999.

We invite clients to join us as we work towards:

* Cultivating strategic partnerships with clients and potential clients to leverage our diversity platform to create and deepen relationships and cultivate business opportunities.

* Encouraging our lawyers to facilitate opportunities for our diverse and women lawyers to develop relationships with clients before and after new matters are received.

* Broadening the pipeline of diverse attorneys by expanding relationships with minority bar associations and other legal diversity organizations through our combined support of these networks.

* Focusing on strengthening mentoring programs for female and diverse attorneys at every level.

* Instituting a program that provides a variety of mentoring, rainmaking and training opportunities that can be accessed by a wide range of diverse attorneys across a variety of underserved communities.

* Engaging our Affinity Groups and their allies as a forum for professional development and business development opportunities, as well as for recruiting and retention assistance and as a social exchange to promote inclusion.

Diversity in Action: Employee Resource Networks

Greenberg Traurig's Employee Resource Networks (Affinity Groups) have the goal of addressing the needs of our attorneys and professionals who are diverse. We support Affinity Groups for our attorneys who are African American, Asian American, Hispanic American, LGBT and women, and we continue to gauge opportunities to expand those groups as our needs and demographics dictate.

The firm's Affinity Groups are as follows:

* African American Affinity Group

* Asian Pacific American Affinity Group

* Hispanic American Affinity Group

* Lesbian, Gay, Bisexual and Transgender (LGBT) Affinity Group

* South Asian American Affinity Group

* Women's Initiative

Our goals include:

* Mentoring of junior attorneys within the specific group;

* Recruitment and retention of diverse attorneys;

* Active participation in organizations addressing specific groups; and

* Serving as a forum for group members to discuss and explore issues and opportunities that will add value to client relationships.

Women's Initiative

As an example of our approach, Greenberg Traurig's firm-wide Women's Initiative focuses on retaining and supporting women attorneys through professional development and work/life balance initiatives, as well as through business development training programs and networking opportunities.

We work with like-minded organizations to address these issues on a broader scale in a variety of industries and communities.

Our program targets:

* Attracting and retaining talented women attorneys.

* Supporting business development for women attorneys.

* Serving as industry leaders.

* Impacting the community through leadership and service.

* Maintaining a culture that benefits women attorneys.

Diversity in Action: Suppliers

Greenberg Traurig is committed to the development of Disadvantaged Business Enterprises and Small Business Enterprises (DBE & SBE) suppliers.

As such:

* All business concerns, large and small, majority- or minority-owned, are afforded an equal opportunity to compete.

* A national director of procurement within the firm supports this practice.

* We are committed to diversity with respect to our vendors and suppliers.

* We are amenable to using diverse vendors and suppliers recommended by clients.

Diversity from the Top Down

Cesar L. Alvarez, Co-Chair of Greenberg Traurig, leads our diversity efforts. This is a matter of personal responsibility for him, having entered the U.S. as an immigrant with humble beginnings.

He has previously been honored as follows:

* "Lifetime Achievement Award," Hispanic National Bar Foundation

* "100 Most Influential Lawyers in America," The National Law Journal

* "50 Most Influential Minority Lawyers in America," The National Law Journal

* "Top Most Powerful Hispanics," The Black Book of Poder

* "25 Best Latinos in Business," Hispanic Magazine, The Power Issue

* "President's Award of Merit for Diversity Efforts," The Florida Bar

* "Spirit of Excellence Award," ABA Commission on Racial and Ethnic Diversity in the Profession

* "Lifetime Achievement Award," Chambers USA Awards for Excellence

* "CEO of the Year" award, Multicultural Law Magazine

* "Attorney of the Year Award," Hispanic National Bar Association


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